Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Tobacco Products Scientific Advisory Committee, 56205-56206 [2011-23185]
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Federal Register / Vol. 76, No. 176 / Monday, September 12, 2011 / Notices
modify, or retain any element of the
workload adjuster.
H. Impact of PDUFA V Enhancements
on User Fee Revenue
Implementing the proposed
enhancements discussed in the previous
sections of this document will add $40.4
million to the PDUFA user fee revenue
amount in FY 2012. The fee revenue
amount for FY 2012 is $652,709,000 as
published by notice in the Federal
Register of August 1, 2011 (76 FR
45831). This amount includes the
additional user fee revenues for drug
safety in FY 2012 totaling $65 million
as specified in the statute. The
additional user fee revenue for the
PDUFA V enhancements translates to a
6-percent increase, and a total base of
$693.1 million in FY 2013. The
following table summarizes the FY 2013
baseline and added resources to support
the new PDUFA V enhancements:
Financial baseline
FY 2012 Baseline 1 .............
Cumulative Inflation Adjustment for FY 2012 ............
Cumulative Workload Adjustment for FY 2012 ......
Fee Revenue Amount for
FY 2012 2 ........................
Dollars
$499,412,000
104,277,000
49,020,000
652,709,000
PDUFA V Enhancements
Increased Staff Capacity
(129 FTE) ........................
Other Direct Costs ..............
Total Statutory Revenue
Amount for FY 2013 3 .....
36,120,000
4,270,000
693,099,000
mstockstill on DSK4VPTVN1PROD with NOTICES
1 In determining the fee revenue amount
for FY 2012, sections 736(b)(4)(A) and
736(b)(4)(B) of the FD&C Act direct the
Secretary of Health and Human Services
(Secretary) to substitute $392,783,000 plus
$65,000,000 (for FY 2012) for the amount in
paragraph (1)(A). Furthermore, paragraph
(1)(B) directs the Secretary to add the amount
of the modified workload adjustment for FY
2007 to the amount in paragraph (1)(A) to
determine the total revenue amount in FY
2012. This total is $499,412,000.
2 As published in the Federal Register of
August 1, 2011 (76 FR 45831).
3 Of this amount, $652,709,000 will be
further adjusted according to the new
statutory provisions to account for inflation
and workload adjustments in determining
fees for FY 2013. These adjustments must be
captured in calculations of user fee revenue
for FYs 2014–2017.
IV. What information should you know
about the meeting?
A. When and where will the meeting
occur? What format will FDA use?
We will convene a public meeting to
hear the public’s views on the proposed
recommendations for reauthorization of
PDUFA. We will conduct the meeting
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18:18 Sep 09, 2011
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on October 24, 2011, at FDA’s White
Oak Campus (see ADDRESSES). The
meeting will include a presentation by
FDA and a series of panels representing
different stakeholder groups identified
in the statute (such as patient advocacy
groups, consumer advocacy groups,
health professionals, and regulated
industry). We will also provide an
opportunity for other organizations and
individuals to make presentations at the
meeting or to submit written comments
to the docket before the meeting.
B. How do you register for the meeting
or submit comments?
If you wish to attend this meeting,
please register by e-mail at:
PDUFAReauthorization@fda.hhs.gov by
October 10, 2011. Your e-mail should
contain complete contact information
for each attendee, including: Name,
title, affiliation, address, e-mail address,
and phone number. Registration is free
and will be on a first-come, first-served
basis, with the exception below. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. On-site
registration on the day of the meeting
will be based on space availability. We
will try to accommodate all persons
who wish to make a presentation. If you
need special accommodations because
of disability, please contact Sunanda
Bahl (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
meeting.
In addition, interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments
regarding this document. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday. To ensure
consideration, all comments must be
received by October 31, 2011.
C. Will meeting transcripts be available?
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.regulations.gov
and https://www.fda.gov. It may be
viewed at the Division of Dockets
Management (see ADDRESSES). A
transcript will also be made available in
either hard copy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
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56205
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
Dated: September 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23251 Filed 9–9–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Tobacco
Products Scientific Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on its Tobacco Products Scientific
Advisory Committee, notify FDA in
writing. FDA is also requesting
nominations for nonvoting industry
representatives to serve on the Tobacco
Products Scientific Advisory
Committee. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for upcoming vacancies
effective with this notice.
DATES: Send letters stating interest in
participating in the selection process to
FDA by October 12, 2011 (see sections
I and II of this document for details).
Concurrently, nomination material for
prospective candidates should be sent to
FDA by October 12, 2011.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to TPSAC@fda.hhs.gov, or by
mail to Caryn Cohen, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT:
Caryn Cohen, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373
(choose Option 4), FAX: 240–276–3761,
e-mail: TPSAC@fda.hhs.gov.
SUMMARY:
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56206
Federal Register / Vol. 76, No. 176 / Monday, September 12, 2011 / Notices
The
Agency requests nominations for
nonvoting industry representatives on
the Tobacco Products Scientific
Advisory Committee.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Tobacco Products Scientific Advisory
Committee
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of Food and
Drugs (the Commissioner) or designee in
discharging responsibilities as they
relate to the regulation of tobacco
products. The Committee reviews and
evaluates safety, dependence, and
health issues relating to tobacco
products and provides appropriate
advice, information, and
recommendations to the Commissioner.
The Committee includes three
nonvoting members who represent
industry interests. These members
include one representative of the
tobacco manufacturing industry, one
representative of the interests of tobacco
growers, and one representative of the
interests of the small business tobacco
manufacturing industry. The
representative of the interests of the
small business tobacco manufacturing
industry may be filled on a rotating,
sequential basis by representatives of
different small business tobacco
manufacturers based on areas of
expertise relevant to the topics being
considered by the Committee.
With this notice, nominations are
sought for the following positions: (1)
One representative of the interests of
tobacco growers, and an alternate to this
representative; (2) a pool of individuals,
with varying areas of expertise, to
represent the interests of the small
business tobacco manufacturing
industry on a rotating, sequential basis;
and (3) an individual to serve as
alternate to the representative of the
tobacco manufacturing industry.
II. Selection Procedure
Any industry organization interested
in participating in the selection of
appropriate nonvoting member(s) to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT and DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations,
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the letter, to serve as the
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16:36 Sep 09, 2011
Jkt 223001
nonvoting member to represent industry
interests on the Committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent the industry
interests.
III. Application Procedure
Individuals may self-nominate and/or
organizations may nominate one or
more individuals to serve as a nonvoting
industry representative (for the roles
specified in this document).
Nominations must include a current
resume or curriculum vitae of the
nominee including current business
address and/or home address, telephone
number, e-mail address if available, and
the role for which the individual is
being nominated. Nominations must
also acknowledge that the nominee is
aware of the nomination unless selfnominated. FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process.)
FDA has a special interest in ensuring
that women, minority groups, and
individuals with physical disabilities
are adequately represented on its
advisory committees and, therefore,
encourages nominations for
appropriately qualified candidates from
these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: September 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23185 Filed 9–9–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
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the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, ‘‘NIAID Contract Review
Meeting 2011’’.
Date: October 3, 2011.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Brandt R. Burgess, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
DHHS/NIH/NIAID, 6700B Rockledge Drive,
MSC 7616, Bethdesda, MD 20892–7616, (301)
451–2584, bburgess@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–23231 Filed 9–9–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; The NIDDK–KUH
Fellowship Review.
Date: October 6, 2011.
Time: 9 a.m. to 12 p.m.
E:\FR\FM\12SEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Notices]
[Pages 56205-56206]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23185]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Tobacco Products Scientific Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on its Tobacco Products
Scientific Advisory Committee, notify FDA in writing. FDA is also
requesting nominations for nonvoting industry representatives to serve
on the Tobacco Products Scientific Advisory Committee. A nominee may
either be self-nominated or nominated by an organization to serve as a
nonvoting industry representative. Nominations will be accepted for
upcoming vacancies effective with this notice.
DATES: Send letters stating interest in participating in the selection
process to FDA by October 12, 2011 (see sections I and II of this
document for details). Concurrently, nomination material for
prospective candidates should be sent to FDA by October 12, 2011.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to TPSAC@fda.hhs.gov, or by mail to Caryn Cohen, Center for
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT: Caryn Cohen, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373 (choose Option 4), FAX: 240-276-
3761, e-mail: TPSAC@fda.hhs.gov.
[[Page 56206]]
SUPPLEMENTARY INFORMATION: The Agency requests nominations for
nonvoting industry representatives on the Tobacco Products Scientific
Advisory Committee.
I. Tobacco Products Scientific Advisory Committee
The Tobacco Products Scientific Advisory Committee (the Committee)
advises the Commissioner of Food and Drugs (the Commissioner) or
designee in discharging responsibilities as they relate to the
regulation of tobacco products. The Committee reviews and evaluates
safety, dependence, and health issues relating to tobacco products and
provides appropriate advice, information, and recommendations to the
Commissioner.
The Committee includes three nonvoting members who represent
industry interests. These members include one representative of the
tobacco manufacturing industry, one representative of the interests of
tobacco growers, and one representative of the interests of the small
business tobacco manufacturing industry. The representative of the
interests of the small business tobacco manufacturing industry may be
filled on a rotating, sequential basis by representatives of different
small business tobacco manufacturers based on areas of expertise
relevant to the topics being considered by the Committee.
With this notice, nominations are sought for the following
positions: (1) One representative of the interests of tobacco growers,
and an alternate to this representative; (2) a pool of individuals,
with varying areas of expertise, to represent the interests of the
small business tobacco manufacturing industry on a rotating, sequential
basis; and (3) an individual to serve as alternate to the
representative of the tobacco manufacturing industry.
II. Selection Procedure
Any industry organization interested in participating in the
selection of appropriate nonvoting member(s) to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT and DATES). Within the subsequent
30 days, FDA will send a letter to each organization that has expressed
an interest, attaching a complete list of all such organizations, and a
list of all nominees along with their current resumes. The letter will
also state that it is the responsibility of the interested
organizations to confer with one another and to select a candidate,
within 60 days after the receipt of the letter, to serve as the
nonvoting member to represent industry interests on the Committee. The
interested organizations are not bound by the list of nominees in
selecting a candidate. However, if no individual is selected within 60
days, the Commissioner will select the nonvoting member to represent
the industry interests.
III. Application Procedure
Individuals may self-nominate and/or organizations may nominate one
or more individuals to serve as a nonvoting industry representative
(for the roles specified in this document). Nominations must include a
current resume or curriculum vitae of the nominee including current
business address and/or home address, telephone number, e-mail address
if available, and the role for which the individual is being nominated.
Nominations must also acknowledge that the nominee is aware of the
nomination unless self-nominated. FDA will forward all nominations to
the organizations expressing interest in participating in the selection
process for the committee. (Persons who nominate themselves as
nonvoting industry representatives will not participate in the
selection process.)
FDA has a special interest in ensuring that women, minority groups,
and individuals with physical disabilities are adequately represented
on its advisory committees and, therefore, encourages nominations for
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: September 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23185 Filed 9-9-11; 8:45 am]
BILLING CODE 4160-01-P
